Land: Israel
Sprache: Englisch
Quelle: Ministry of Health
SELEXIPAG
J-C HEALTH CARE LTD
B01AC27
FILM COATED TABLETS
SELEXIPAG 600 MCG
PER OS
Required
ACTELION PHARMACEUTICALS LTD., SWITZERLAND
SELEXIPAG
Uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II-III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies.Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease
2022-02-28
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only Uptravi ® 200 microgram, Uptravi ® 400 microgram, Uptravi ® 600 microgram, Uptravi ® 800 microgram, Uptravi ® 1,000 microgram, Uptravi ® 1,200 microgram, Uptravi ® 1,400 microgram, Uptravi ® 1,600 microgram Film-coated tablets The active ingredient and its quantity: Uptravi 200 micrograms: each film-coated tablet contains 200 micrograms of selexipag Uptravi 400 micrograms: each film-coated tablet contains 400 micrograms of selexipag Uptravi 600 micrograms: each film-coated tablet contains 600 micrograms of selexipag Uptravi 800 micrograms: each film-coated tablet contains 800 micrograms of selexipag Uptravi 1,000 micrograms: each film-coated tablet contains 1,000 micrograms of selexipag Uptravi 1,200 micrograms: each film-coated tablet contains 1,200 micrograms of selexipag Uptravi 1,400 micrograms: each film-coated tablet contains 1,400 micrograms of selexipag Uptravi 1,600 micrograms: each film-coated tablet contains 1,600 micrograms of selexipag For the list of inactive ingredients, please see section 6 Additional information . Read this entire leaflet carefully before using this medicine. This leaflet contains concise information about the medicine. If you have any further questions, refer to your doctor or pharmacist. This medicine has been prescribed for the treatment of your illness. Do not pass it on to others. It may harm them, even if you think that their illness is similar. This medicine is intended for patients over 18 years of age. Patient Titration Guide In addition to the Patient Leaflet, a Titration Guide for the patient is provided with the Uptravi 200 microgram pack . This guide contains important safety information that you must be aware of and adhere to before starting and during the course of treatment with Uptravi. Read the Titration Guide for the patient and patient leaflet before using the preparation. Keep the guide for furthe Lesen Sie das vollständige Dokument
1 Uptravi_PI_November-2023 PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT UPTRAVI ® 200 microgram film-coated tablets UPTRAVI ® 400 microgram film-coated tablets UPTRAVI ® 600 microgram film-coated tablets UPTRAVI ® 800 microgram film-coated tablets UPTRAVI ® 1000 microgram film-coated tablets UPTRAVI ® 1200 microgram film-coated tablets UPTRAVI ® 1400 microgram film-coated tablets UPTRAVI ® 1600 microgram film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION UPTRAVI ® 200 microgram Each film-coated tablet contains 200 micrograms of selexipag. UPTRAVI ® 400 microgram Each film-coated tablet contains 400 micrograms of selexipag. UPTRAVI ® 600 microgram Each film-coated tablet contains 600 micrograms of selexipag. UPTRAVI ® 800 microgram Each film-coated tablet contains 800 micrograms of selexipag. UPTRAVI ® 1,000 microgram Each film-coated tablet contains 1,000 micrograms of selexipag. UPTRAVI ® 1,200 microgram Each film-coated tablet contains 1,200 micrograms of selexipag. UPTRAVI ® 1,400 microgram Each film-coated tablet contains 1,400 micrograms of selexipag. UPTRAVI ® 1,600 microgram Each film-coated tablet contains 1,600 micrograms of selexipag. For the full list of excipients, see section 6.1. Patient Titration Guide The marketing of Uptravi is subject to risk management plan (RMP) including a 'Patient Titration Guide'. The patient titration guide emphasizes important safety information that the patient should be aware of before and during the treatment. The patient titration guide is included in the Uptravi 200 microgram pack. Please explain to the patient the need to review the guide before starting treatment. 2 Uptravi_PI_November-2023 3. PHARMACEUTICAL FORM Film-coated tablet UPTRAVI ® 200 microgram Round, light-yellow, film-coated tablets with “2” debossed on one side. UPTRAVI ® 400 microgram Round, red, film-coated tablets with “4” debossed on one side. UPTRAVI ® 600 microgram Round, light-violet, film-coated tablets with “6” debossed on one side. UPTR Lesen Sie das vollständige Dokument